Attachment 2 - Statement of Work 15 Aug 23.pdf

Statement of Work

Title: Wastewater Surveillance Testing Services

Part I – General Scope of Work

C.1 Background and Need

The National Wastewater Surveillance System (NWSS) was established to provide community-level data on infection trends using an approach that is independent of healthcare access and clinical testing capacity. Wastewater data has been used to support state, tribal, local and territorial (STLT) response decision-making, such as resource allocation, siting of mobile testing units, refining health messaging, and near-term forecasting of cases and hospitalizations.

NWSS is a Centers for Disease Control and Prevention (CDC)-coordinated surveillance system that is implemented through STLT health departments. By August 2022, 47 state, local, and territorial public health jurisdictions had received funding to support wastewater surveillance activities. However, implementation of this novel surveillance approach requires considerable effort, resources, and coordination at the state and local level, and STLT health departments are already overburdened providing other COVID response activities. Thus, not all funded jurisdictions are able to rapidly implement this novel surveillance approach or provide substantial coverage of the communities in their jurisdictions. Some STLT jurisdictions do not have the capacity to implement wastewater surveillance activities and are lacking access to this valuable source of public health data.

Supplementing STLT capacity through commercial wastewater testing services is a critical and urgent need to support the nation's ongoing response to the COVID-19 health emergency.

With the emergence of new variants, there is a sustained risk of surges throughout the US.

Wastewater data can provide an early warning of new surges to allow more time to allocate resources. Wastewater data also provides a robust measure of community infection trends at the height of surges when clinical testing can have insufficient capacity. This testing capacity would allow rapid expansion of the NWSS network to a truly national system providing COVID surveillance data for US territories, tribal nations, and all 50 states.

C.2 Project Objectives

The Wastewater Testing Services contract provides the Centers for Disease Control and Prevention

(CDC), Division of Foodborne, Waterborne and Environmental Diseases (DFWED), Waterborne Disease

Prevention Branch (WDPB) a mechanism to obtain services that support wastewater surveillance testing and aligns with public health priorities for CDC.

The purpose of this task is to provide flexible wastewater testing services that complements existing wastewater surveillance networks managed by STLT health departments to support ongoing COVID and Mpox responses and prepare for future public health responses.

• The base service required includes facilitating wastewater sample collection and shipment with selected utilities, conducting quantitative SARS-CoV-2 testing, and timely data submission to

CDC.

• The testing period and number of wastewater sites will be scaled as needed, with a minimum order of 100 sites and up to 400 sites.

• The contract will provide national testing coverage including territories and Tribal communities.

Contractor is required to support all 10 HHS regions.

C.2.1. Adaptability for future responses

• To prepare for future responses, the contract will facilitate ordering additional add-on quantitative

PCR-based tests or tiled amplicon sequencing through options which can be exercised more than once, up to a stated maximum, or not at all. This service will be used for pathogens that can be adequately measured using the same sample processing methods as SARS-CoV-2. Research and development costs are not covered by the contract.

• Mpox quantitative PCR-based testing may be ordered as an add-on test using the same processed wastewater samples used for SARS-CoV-2 testing.

C.3 Contract Structure

The contract will contain base tasks and optional CLINs identified which can be exercised more than once, up to a stated maximum. In the event of a public health emergency, the number of sites may be scaled up beyond that of the original number of sites, but will not exceed 400 sites per month. This change will be accomplished through a bilateral modification.

C.4 Scope of work

The purpose of this contract is to provide wastewater testing services that supplement the existing wastewater surveillance systems in STLT health departments and prepare for future public health responses.

The requirements for this wastewater testing services contract are:

1. Establish service relationships with selected wastewater testing facilities. Facilities will be selected for testing by CDC in coordination with STLT health departments. Vendors will provide sampling and shipping supplies at no cost to the participating utilities. Wastewater samples will be collected twice per week. Vendors must establish a mechanism to collect the utility metadata required for NWSS data submission (See NWSS data dictionary for required data elements https://www.cdc.gov/nwss/reporting.html#data-dictionary).

2. Quantitative PCR-based SARS-CoV-2 testing for all samples and data submission to CDC within 36 hours of sample receipt by the vendor. Test method must meet the data submission standards for NWSS (See NWSS data dictionary for required data elements https://www.cdc.gov/nwss/reporting.html#data-dictionary).

3. Optional tiled amplicon sequencing of SARS-CoV-2 of all samples that have the minimum

SARS- CoV-2 RNA concentrations necessary to generate high quality sequence data (i.e., Ct ≥

35). Raw sequence data must be submitted to CDC within 10 calendar days of sample receipt by the vendor.

1. Add-on testing for mpox and other pathogens based on public health need. These tests will be either quantitative PCR-based assays or tiled amplicon sequencing.

http://www.cdc.gov/nwss/reporting.html#data-dictionary)

C.5 Technical Requirements

5.1 - Task 1: Establish wastewater testing services with selected wastewater facilities to support twice weekly sample collection and shipment to the testing laboratory.

Wastewater sites will be selected by CDC and STLT health departments to supplement existing wastewater surveillance systems and provide testing coverage in communities that meet public health priorities. CDC will confirm the utilities’ interest in participating and provide their contact information to the vendor prior to issuance of an option. The number of wastewater sites included in each task year will be scaled to the public health need, with a minimum of 100 and a maximum of 400 sites per year.

Vendors will provide sampling and shipping kits to each facility in a manner that supports twice weekly sample collection. Instruction for collecting samples, reporting facility metadata as required by NWSS

(https://www.cdc.gov/healthywater/surveillance/wastewater-surveillance/data-reporting-analytics.html#data-dictionary), and packaging the sample for shipment per Department of Transportation shipping regulations shall be provided. Vendors are responsible for maintaining an adequate supply of testing and shipping kits to support the continuous flow of samples during the testing period for each year. Composite sampling is preferred, but vendors should be able to receive grab samples as well if the facility does not have a composite autosampler. Sampling and shipping kits, including shipping fees, shall be provided at no cost to the participating facilities. Sample volume shall be sufficient to allow SARS-

CoV-2 testing and sequencing, retesting if necessary, and archiving of no less than 15 ml raw wastewater sample with CDC. Sample remainders should be frozen and shipped on dry ice to the CDC Biorepository at least every 4 weeks and up to weekly based on vendor storage capacity.

In addition to sample collection services, vendors will maintain a data management system that facilitates tracking of facility participation and compliance with the sampling schedule. The data system should also track samples from receipt through testing to data reporting. Vendors will be responsible monitoring facility compliance and documenting efforts to support and restore compliance with the sample collection schedule.

Deliverables: See deliverables table

5.2- Task 2: SARS-CoV-2 quantitative testing.

The vendor shall conduct laboratory analysis to quantify SARS-CoV-2 RNA (i.e., report results as copies/volume not Ct) via reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) or digital/droplet digital polymerase chain reaction (dPCR or ddPCR). Methods that report only Ct values are not acceptable. The testing protocol must include measurement of recovery efficiency, matrix inhibition evaluation, and human fecal normalization that meet the requirements for the National

Wastewater Surveillance System as described here: https://www.cdc.gov/nwss/reporting.html#data-dictionaryh. A complete laboratory protocol, including sample processing, nucleic acid extraction, and

PCR, must be provided to CDC to ensure proper analysis and interpretation of the results.

Results shall be submitted to CDC within 36 hours of sample receipt by the vendor. Each sample result must include all of the required data fields (https://www.cdc.gov/nwss/reporting.html#data-dictionary) to be considered complete. Required QA/QC controls include extraction blanks, negative controls, positive controls, and standard curves (if using RT-qPCR).

http://www.cdc.gov/healthywater/surveillance/wastewater-surveillance/data-reporting-http://www.cdc.gov/nwss/reporting.html#data-

SARS-CoV-2 quantitative testing will be included in all years. The processing and extraction methods used for this task must produce nucleic acid extracts that are appropriate and sufficient for the add-on testing described in tasks 3 through 6.

Deliverables: See deliverables table

5.3 - Task 3: Add-on SARS-CoV-2 tiled amplicon sequencing.

The vendor shall conduct SARS-CoV-2 sequencing that is appropriate for variant detection. Tiled amplicon methods, such as those used for variant determination in clinical samples, are most appropriate for wastewater samples to overcome challenges of genome fragmentation, short reads, potentially high viral diversity, and the relatively low abundance of viral RNA. The sequencing method should ensure that there is not a drop in coverage for the S-gene. Metagenomic sequencing of total RNA or Sanger sequencing of amplicons is not appropriate or acceptable. Sequence analysis shall be conducted on up to one representative sample (individual or pooled) per week from each participating utility. Only samples that have sufficient SARS-CoV-2 concentrations (e.g., Ct value less than a pre- determined threshold) should be considered for sequencing.

Raw sequence data and sample metadata shall be submitted to the National Center for Biotechnology

Information (NCBI) within 10 calendar days of sample receipt by the vendor.

Deliverables:

• Required on first option exercised o Data submission template o Data dictionary o Laboratory protocol

• Required for all options exercised o Raw SARS-CoV-2 sequence data once per week for up to 400 sites o Sequencing manifest once per week o Testing performance report once per month

5.4 – Optional Task 4: Add-on mpox virus quantitative testing.

The vendor shall conduct laboratory analysis to quantify mpox virus DNA (i.e., report results as copies/volume not Ct) via reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) or digital/droplet digital polymerase chain reaction (dPCR or ddPCR). Mpox testing will be conducted on all wastewater samples collected under Task 1 (e.g., two samples per week from all sites) during the period of performance as represented by CLIN X003. Methods that report only Ct values are not acceptable. The non-Variola orthopox assay is preferred (see Test Procedure: Non-variola Orthopoxvirus generic real-time PCR assay for primer and probe sequences, https://www.cdc.gov/poxvirus/monkeypox/lab-personnel/index.html),. A monkeypox-specific assay is acceptable as long as all positive samples are confirmed with a Clade 2-specific assay; any monkeypox-positive/Clade 2-negative samples must be reported as a potential Select Agent detection. The testing protocol must include measurement of recovery efficiency, matrix inhibition evaluation, and human fecal normalization that meet the data reporting requirements for the National Wastewater Surveillance System as described here: https://www.cdc.gov/nwss/reporting.html. A complete laboratory protocol must be provided to CDC to ensure proper analysis and interpretation of the results.

Results shall be submitted to CDC within 36 hours of sample receipt by the vendor. Each sample result must include all of the required data fields (https://www.cdc.gov/nwss/reporting.html) to be considered complete. Required QA/QC controls include extraction blanks, negative controls, positive controls, and standard curves (if using RT-qPCR).

o Data submission template o Data dictionary o Laboratory protocol

• Required for all options exercised o Quantitative mpox data twice per week for up to 400 sites

Optional Testing: Contractor may be asked to perform mpox virus quantitative testing during the period of the performance as represented by CLIN X003 in their respective performance periods; optional testing

CLINs may be exercised multiple times, up to the stated maximum, during the period of performance in quantities of 1-12 months.

Maximum: 12 Months

5.5 – Optional Task 5: Add-on quantitative PCR-based pathogen testing.

CDC may require testing for additional pathogens based on public health need. The specific pathogens cannot be anticipated at this time, but consideration for a contract will require that the pathogen is recoverable from wastewater using the same methods that eligible vendors are using for SARS-CoV-2 and detectable using PCR-based methods. Test frequency and number will not exceed that of SARS-

CoV-2 as described in Tasks 1 and 2.

Additional PCR-based pathogen testing will not include assay development.

o Data submission template o Data dictionary o Laboratory protocol

• Required for all options exercised o Quantitative data at frequency specified by CDC for up to 400 sites

Optional Testing: Contractor may be asked to perform testing for additional pathogens during the period of http://www.cdc.gov/poxvirus/monkeypox/lab-personnel/index.html) https://www.cdc.gov/nwss/reporting.html http://www.cdc.gov/nwss/reporting.html) performance as represented by CLIN X004 in their respective performance periods; optional testing

CLINs may be exercised multiple times, up to the stated maximum, during the period of performance in quantities of 1-12 months

Maximum: 12 months

5.6 – Optional Task 6: Add-on tiled amplicon sequencing for additional pathogens. CDC may exercise options to sequence mpox or additional pathogens in alignment with task 5 based on public health need. To be considered for this task, a tiled amplicon approach must be commercially available for the target pathogen. Test frequency and number will not exceed that of SARS-

CoV-2 as described in Tasks 1 and 2.

o Data submission template o Data dictionary o Laboratory protocol

• Required for all options exercised o Raw sequence data at frequency specified by CDC for up to 400 sites

Optional Testing: Contractor may be asked to perform testing for additional pathogens during the period of the performance as represented by CLIN X005 in their respective performance periods; optional testing

CLINs may be exercised multiple times, up to the stated maximum, during the period of performance in quantities of 1-12 months.

Maximum: 12 months

5.7 – Task 7: Data and program management.

The vendor shall manage their performance to ensure compliance with all requirements of the contract.

The vendor shall assign a Program Manager who will ensure the vendors’s performance complies with all requirements and will be the primary point of contact for the work to be performed. The Program

Manager shall have sufficient corporate authority to direct, execute, and control all elements of the task and ensure that all necessary management, business, contracts, engineering, implementation, and maintenance resources are available and sufficient, both in numbers and qualifications, to successfully perform all the tasks required by the contract.

The vendor shall continuously monitor the performance of this contract, and of all subcontracts, to provide the Government with a timely assessment of program progress and problems and to control contract activities to include Subcontractor and/or vendor activities. This should involve the development and execution of a Communication Plan to include the method, approach, and cadence for communicating status, issues, and risks to CDC through the COR and for communicating with stakeholders outside CDC.

Documentation of adherence to the communication plan must be included in the monthly update deliverable.

It is imperative that the vendor monitors the facilities for adherence to the testing schedule. The absence of data collection can impair the monitoring of tracking SARS-CoV-2 concentrations in sewage. This is a voluntary program, and a facility may choose to no longer participate, or they may not have the resources to comply with the testing schedule. The vendor shall contact a facility when they miss a collection date.

If a facility misses an entire week of sample collection, the vendor shall notify the project manager with a written correspondence of the interaction with the facility and whether the testing schedule has been resolved. If the vendor cannot contact the facility after three attempts, the vendor should notify CDC. If a facility consistently misses sampling events, the vendor shall notify CDC. CDC may opt to replace non-responsive facilities.

It is imperative that the data received from the vendor are error-free and complete. This includes proper file type, proper file format, accurate column headings, consistent data standards, complete submissions, and accurate data. The technical monitor will notify the vendor if they find data quality issues. The vendor is responsible to isolate and resolve these issues. If the same issue occurs multiple times, the CDC technical monitor may ask for a corrective action plan to resolve the issues. In the corrective action plan, the vendor will provide the steps to be taken to prevent the issue from re-occurring.

Part II – Base Year Work Requirements

The Contractor shall provide additive data and support to CDC’s NWSS by measuring SARS-CoV- 2

RNA in community wastewater, compiling that data, and securely transferring the derived data to the

NWSS DCIPHER data system in a format that corresponds with the NWSS Data Dictionary format to integrate within the existing data infrastructure. The contractor shall conduct twice weekly testing of wastewater for SARS-CoV-2, as a leading indicator for local re-emergence events. Additionally, sequencing of positive samples can provide information on the presence of variants of concern in the contributing communities.

Testing services will be provided to a total of 400 wastewater facilities across all HHS regions through the base year. CDC will provide contact information for utilities that are interested and able to participate. The contractor shall have the capacity to work with communities across all 50 states and territories including federally recognized Indian tribes according to IHS. Contractor must adhere to the following testing coverage schedule:

Table 1: Testing Coverage Options by HHS Region HHS Regions 1-10

Sites enrolled in first 4 weeks

Sites enrolled in the first

6 weeks

Sites enrolled in first 12 weeks

Total sites enrolled 400

The Contractor must provide all staff, equipment, supplies, and logistical support to perform all services described in this SOW, including but not limited to, identification of sample collection location, sample analysis, and data management. This will include supplying sample collection supplies and shipping materials at no cost to the participating utilities.

Requirements

● Contractor will provide self-contained sampling kits and shipping materials to participating wastewater facilities for 24-hour composite samples (if capacity available at wastewater facility), or grab samples. Sample volumes must be sufficient to allow all required testing, repeat testing if necessary, and at least 15 ml raw wastewater for archiving by CDC.

● Contractor is responsible for maintaining an adequate supply of testing kits and shipping materials to support the continuous flow of testing throughout the contract period.

● The contractor will conduct testing of wastewater samples from each enrolled facility twice per week, producing 200-800 test results per week.

● The contractor will deliver to CDC the test results within 36 hours of receipt of wastewater sample.

● The contractor shall conduct laboratory analysis to quantify SARS-CoV-2 RNA via reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) or digital/droplet digital polymerase chain reaction (dPCR or ddPCR). The testing protocol must include measurement of recovery efficiency, matrix inhibition evaluation, and human fecal normalization that meet the requirements for the National Wastewater Surveillance System as described here:

https://www.cdc.gov/healthywater/surveillance/wastewater-surveillance/testing-methods.html

● Required QA/QC controls include extraction blanks, negative controls, positive controls, standard curves (if using RT-qPCR), and data management policies.

● The contractor shall conduct SARS-CoV-2 sequencing that is appropriate for variant detection http://www.cdc.gov/healthywater/surveillance/wastewater-surveillance/testing-methods.html and shall submit the raw sequence data and sample metadata to NCBI within 10 days of sample receipt by the Contractor. Next generation sequencing that accounts for genome fragmentation, short reads, potentially high viral diversity, and the relatively low abundance of viral RNA, such as tiled amplicon approaches are acceptable. The sequencing method should ensure that there is not a drop in coverage for the S-gene. Metagenomic sequencing of total RNA or Sanger sequencing of amplicons is not appropriate/acceptable. Sequence analysis shall be conducted on up to one representative sample (individual or pooled) per week from each participating utility.

Only samples that have sufficient SARS-CoV-2 concentrations (e.g., Ct value less than a pre-determined threshold) should be considered for sequencing.

● Sample remainders, including at least 15 ml of raw wastewater and any remaining extracted

RNA will be shipped to the CDC Biorepository for archiving. Samples will be shipped at a temperature that will maintain sample integrity (i.e. ice packs or dry ice) packs. Samples should be shipped at least monthly.

Facility Monitoring

It is imperative that the contractor monitors the facilities for adherence to the testing schedule. The absence of data collection can impair the monitoring of tracking SARS-CoV-2 concentrations in sewage.

This is a voluntary program, and a facility may choose to no longer participate, or they may not have the resources to comply with the testing schedule.

● The contractor shall contact a facility when they miss a collection date.

● If a facility misses an entire week of sample collection, the contractor shall notify the project manager with a written correspondence of the interaction with the facility and whether the testing schedule has been resolved. If a contractor cannot contact the facility after three attempts, the contractor should notify the facility that they are being replaced in the program and the contractor shall replace non-responsive facility with a new facility to be selected in coordination with CDC.

● If a facility consistently misses sampling events, the contractor shall replace the non-responsive facility with a new facility to be selected in coordination with CDC.

Data Quality

It is imperative that the data received from the contractor are error free and complete. This includes proper file type, proper file format, accurate column headings, consistent data standards, and accurate data. The program manager will notify the contractor if they find data quality issues. The contractor is responsible to isolate and resolve these issues. If the same issue occurs multiple times, the program manager may ask for a corrective action plan to resolve the issues. In the corrective action plan, the contractor will provide the steps to be taken to prevent the issue from re-occurring.

Contractor Program Management

The Contractor shall manage their performance to ensure compliance with all requirements of the contract. The Contractor shall assign a Program Manager who will ensure the Contractor’s performance complies with all requirements and will be the primary point of contact for the work to be performed.

The Program Manager shall have sufficient corporate authority to direct, execute, and control all elements of the task and ensure that all necessary management, business, contracts, engineering, implementation, and maintenance resources are available and sufficient, both in numbers and qualifications, to successfully perform all the tasks required by the contract.

The Contractor shall continuously monitor the performance of this contract, and of all subcontracts, to provide the Government with a timely assessment of program progress and problems and to control contract activities to include Subcontractor and/or vendor activities. This should involve the development and execution of a Communication Plan to include the methodology and approach for communicating status, issues, and risks to CDC through the COR and for communicating with stakeholders outside CDC.

Data Use

The Contractor acknowledges that samples subject to this contract are sensitive, and violations of this section shall be deemed a material breach of the Contract.

All data generated through this contract are the sole property of CDC. The contractor may provide data reports to participating facilities with approval by CDC. Under no circumstances may Contractor use this data for purposes not explicitly described in this contract without prior written approval from CDC.

Examples of prohibited uses include, but are not limited to, inclusion in research publications, data sharing with other public or private entities, or incorporation into marketing materials. The Contractor shall report to CDC, both verbally and in writing, any instance in which a sample or any other data obtained in connection with this contract is subpoenaed or becomes the subject of a court or administrative order or other legal process (including a public records request under the Freedom of

Information Act). The Contractor shall provide such report to CDC as soon as feasible upon receiving or otherwise becoming aware of the legal process; provided, that the Contractor shall provide such report no later than five (5) business days prior to the applicable response date. If CDC determines that it shall respond directly, the Contractor shall cooperate and assist CDC in its response.

The Contractor shall implement administrative, physical and technical safeguards that reasonably and appropriately protect the samples and that prevent use or disclosure of such data other than as provided for by this Contract. As soon as possible, but in any event no later than twenty-four (24) hours after

Contractor becomes aware of a misuse or mis-disclosure not permitted under the Contract, the Contractor shall verbally report the Event to CDC with as much of the details as possible and shall follow such verbal report within three (3) business days with a written report outlining the misuse or mis-disclosure and shall provide any additional information as CDC may reasonably request.

SECTION 4 – TASKS TO BE PERFORMED

Phase 1: Rapid ramp-up of testing deployment and establishment of data transfer protocols between

Contractor and CDC DCIPHER data system.

Duration: 4 weeks. The contractor must begin to continuously test as soon as possible. Within 4 weeks of contract initiation, contractor must have enrolled, provided sampling kits, and begin receiving wastewater samples from the number of wastewater facilities indicated in Table 1.. Facilities participating in previous

CDC testing contracts shall be given priority for enrollment with testing initiation as soon as possible after contract award.

1. Establish data reporting format and test data transfer protocols between Contractor and DCIPHER.

Data transfer must be via a secure mechanism, such as a secure file transfer site or API. The format shall comply with the NWSS-DCIPHER data dictionary. Any additional fields necessary to comply with reporting shall be appended to the tail of the NWSS-DCIPHER dataset. (NWSS-

DCIPHER data dictionary is available at https://www.cdc.gov/healthywater/surveillance/wastewater- surveillance/data-reporting-analytics.html#data-dictionary)

2. Enroll wastewater treatment plants in priority areas for the National Wastewater Surveillance

System in coordination with CDC.

3. Provide training to wastewater facility staff on proper collection, packaging, and shipping of wastewater samples to the contractor. Sample collection and shipping protocols are provided.

Shipping costs are covered by the contractor.

http://www.cdc.gov/healthywater/surveillance/wastewater-

Phase 1 Deliverables:

● Kickoff Meeting within one week of contract award date

● Weekly status report that includes a list of facilities recruited, number of sampling kits shipped, timeline for testing initiation, and any issues that may delay successful completion of phase 1.

● Weekly project meeting with CDC contract management team

● Data submission template and test submission.

● Data dictionary

● Data collection instrument for required wastewater treatment plant metadata.

● List of facilities that are participating in this contract. Whenever there is a change of participating facilities, this file must be updated and delivered to CDC. This file shall include:

o Wastewater treatment plant name o ZIP code of treatment plant o Wastewater treatment plant jurisdiction (state, territory, or Tribal Nation) o Population covered o NPDES_ID o County or Counties Served

● Meeting to review the laboratory processing and testing protocols and data analysis to ensure proper use of the data

● Laboratory protocol for sequencing for variant tracking including library generation, primers used, sequencing platform, quality control, and sample inclusion criteria for sequence analysis

Phase 2: Testing wastewater samples and reporting data twice per week including quality assurance and quality control (QA/QC). Facility enrollment will continue until all sites have been enrolled, provided sampling kits and are submitting samples.

Duration: 44 weeks

1. Contractor will provide self-contained sampling kits and shipping materials to participating wastewater facilities for 24-hour composite samples (if capacity available at wastewater facility), or grab samples. Sample volume should be sufficient to conduct all required testing, allow repeat testing if needed and have at least 15 ml raw wastewater remaining for archiving at CDC.

2. Contractor conducts laboratory analysis to quantify SARS-CoV-2 RNA via reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) or digital/droplet digital polymerase chain reaction (dPCR or ddPCR). The testing protocol must include measurement of recovery efficiency, matrix inhibition evaluation, and human fecal normalization that meet the requirements for the National Wastewater Surveillance System as described here:

https://www.cdc.gov/healthywater/surveillance/wastewater- surveillance/testing-methods.html

3. Contractor implements QA/QC measures to ensure the validity of the reported data as described here: https://www.cdc.gov/healthywater/surveillance/wastewater-surveillance/testing-methods.html. Required QA/QC controls include extraction blanks, negative controls, positive controls, standard curves (if using RT-qPCR), and data management policies.

4. Contractor consistently reports quantitative data to CDC within 36 hours of sample receipt by the contractor.

5. Contractor provides regular data streams to DCIPHER, at a minimum of 2x/week.

6. Contractor generates SARS-CoV-2 sequence data that is appropriate for variant detection and http://www.cdc.gov/healthywater/surveillance/wastewater-submits the raw sequence data and sample metadata to NCBI within 10 days of sample receipt by the Contractor. Sequence analysis shall be conducted on up to one representative sample

(individual or pooled that meets the predetermined criteria for sequence analysis) per week from each participating utility. Pooling of multiple weeks or across sites is not acceptable.

Phase 2 Deliverables:

● Quantitative SARS-CoV-2 data from a minimum of 400 and up to 800 samples per week with a minimum data upload frequency of twice per week. Submitted data must be complete with all elements of the data dictionary included.

● Sequence data uploaded to designated NCBI database within 10 days of sample receipt by the

Contractor for all samples meeting predetermined sequencing criteria.

● Weekly project meeting with CDC contract management team

● Weekly sequencing manifest with sequencing determination (i.e., whether samples meet criteria for sequencing), sample pooling, sequence submission date to NCBI, and NCBI sample accession number for all wastewater samples received by the Contractor.

● Biweekly testing performance report including QA/QC statistics, turnaround time, and percent of samples requiring repeat testing

● Monthly status report that includes a list of facilities participating, any issues with facility noncompliance with sample collection or shipping protocols, and contractor’s efforts to resolve issues

Phase 3: Final data cleaning and submission

Duration: 4 weeks

Phase 3 Deliverables:

● Weekly project meeting with CDC contract management team

● Final report

SECTION 5 – GOVERNMENT FURNISHED MATERIALS

CDC will provide a list of priority wastewater treatment facilities for enrollment. CDC will also provide written documentation that this work is part of the National Wastewater Surveillance System to support enrollment efforts.

SECTION 6 – PERIOD OF PERFORMANCE

The base period of performance is 12 months. The base period is divided into three phases

● Phase 1 – 4 weeks

● Phase 2 – 44 weeks

● Phase 3 – 4 weeks

SECTION 7 – DELIVERABLES/REPORTING SCHEDULE

Items Description Quantity or No.

of

Delivery Date Deliver To

Copies

Kickoff call Call with project team, technical monitor (TM) and contracting officer representative (COR)

1 Within 7 calendar days of award

TM, COR

Phase 1 status

Reports

Weekly report including facilities recruited, sampling kits shipped, timeline for testing initiation, and any issues with startup.

4 Weekly for first four weeks (Phase 1)

TM, COR

Weekly project meetings

Weekly meeting with

CDC contract management team

52 Weekly TM, COR

Data submission template

Example data file with format that will be used to submit all quantitative data

1 First 14 calendar days

TM, COR

Data dictionary

Data dictionary defining all variables including units and reporting format

1 First 14 calendar days

TM, COR

Data collection instrument

Form used to collect sample and facility metadata from wastewater facilities

1 First 14 calendar days

TM, COR

List of participating facilities

List of participating facilities including facility name, ZIP code, jurisdiction, NPDES_ID, county or counties served

At least 1 Within first 14 calendar days and updated within 5 days whenever changes occur

TM, COR

Items Description Quantity or No.

of Copies

Delivery Date Deliver To

Laboratory protocol

Full protocol including wastewater processing, nucleic acid extraction, primers used, and quality control. For sequencing, library generation, sequencing platform, and sample inclusion criteria

1 Within 14 calendar days of award

Quantitative

SARS-CoV-2 data

SARS-CoV-2 data with all required elements of data dictionary included

200-400/week in Phase 1 up to 800/week in Phase 2

Twice weekly beginning no later than week 3

TM, COR

*SARS-CoV-2 sequence data

Raw SARS-CoV-2 sequence data from samples meeting inclusion criteria uploaded to NCBI

Up to 400/week Weekly beginning week 3

TM, COR

*Sequencing manifest

Report including sequencing status for all samples, sample pooling, NCBI submission date and accession number

48 Weekly beginning week 4

TM, COR

Testing performance report

Report including

QA/QC statistics, turnaround time, percent of samples requiring retest

26 Biweekly beginning week 2

TM, COR

Monthly status report

Report including list of participating facilities, any facility compliance issues and efforts to resolve

12 Monthly beginning week 4

TM, COR

Final report Report documenting satisfactory completion of all deliverables

1 At the end of each contract year

*deliverable is only applicable if optional CLIN has been exercised.

SECTION 8 – REFERENCE MATERIALS

N/A

SECTION 9 – POINT OF CONTACT INFORMATION

The Point of Contact (POC) for this procurement is:

Dr. Amy Kirby

Centers for Disease Control and Prevention 1600 Clifton Rd Bldg 23 9th Floor., MS H23-9 Atlanta, Georgia 30329.

Telephone Number: 404-718-3161 E-mail Address: agk1@cdc.gov

Preferred method of communication: Email mailto:agk1@cdc.gov

The Contracting Officer’s Representative (COR) for this procurement is:

Dr. LaQuasha Gaddis

Centers for Disease Control and Prevention 1600 Clifton Rd Bldg 23 9th Floor., MS H23-9 Atlanta, Georgia 30329.

Telephone Number: 404-639-2499

Email Address: dwn2@cdc.gov

Preferred method of communicaiton: Email

SECTION 10 – PAYMENT TERMS

The payment terms for this contract are to be Firm Fixed Price.

SECTION 11 - SPECIAL CONSIDERATIONS

Electronic and Information Technology Accessibility

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/standards.htm.

(c) The Section 508 accessibility standards applicable to this contract are: 1194. 205 WCAG 2.0 Level A & AA Success Criteria

302 Functional Performance Criteria

502 Inoperability with Assistive Technology 504 Authoring Tools

602 Support Documentation

603 Support Services

In order to facilitate the Government's determination whether proposed EIT supplies meet applicable

Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment

Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable

Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and documentation detail - whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS

Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508.

In order to facilitate the Government's determination whether proposed EIT services meet applicable

Section 508 accessibility standards, offerors must provide enough information to assist the Government in mailto:dwn2@cdc.gov http://www.hhs.gov/web/508 http://www.hhs.gov/web/508 http://www.access-board.gov/sec508/standards.htm http://www.access-board.gov/sec508/standards.htm http://hhs.gov/web/508 http://hhs.gov/web/508 determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(e) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

SECTION 12 – IT Security Compliance

Standard-1: Procurements Requiring Information Security and/or Physical Access Security

A. Baseline Security Requirements

1) Applicability. The requirements herein apply whether the entire contract or order (hereafter

“contract”), or portion thereof, includes either or both of the following:

a. Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) employee will have or will be given the ability to have, routine physical

(entry) or logical (electronic) access to government information.

b. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor) employee will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart

2.1 definition of “information technology” (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

2) Safeguarding Information and Information Systems. In accordance with the Federal

Information Processing Standards Publication (FIPS)199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor (and/or any subcontractor) shall:

a. Protect government information and information systems in order to ensure:

● Confidentiality, which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;

● Integrity, which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and

● Availability, which means ensuring timely and reliable access to and use of information.

b. Provide security for any Contractor systems, and information contained therein, connected to an HHS network or operated by the Contractor on behalf of HHS regardless of location. In addition, if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less, bring the situation to the attention of the other party.

http://508.hhs.gov/ http://508.hhs.gov/ https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html

c. Adopt and implement the policies, procedures, controls, and standards required by the HHS

Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain the HHS Information Security Program security requirements, outlined in the HHS Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing fisma@hhs.gov.

d. Comply with the Privacy Act requirements and tailor FAR clauses as needed.

3) Information Security Categorization. In accordance with FIPS 199 and National Institute of

Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to

Guide for Mapping Types of Information and Information Systems to Security Categories, Appendix C, and based on information provided by the ISSO, CISO, or other security representative, the risk level for each Security Objective and the Overall Risk Level, which is the highest watermark of the three factors (Confidentiality, Integrity, and Availability) of the information or information system are the following:

Confidentiality: [ x ] Low [ ] Moderate [ ] High Integrity: [ x ] Low [ ] Moderate [ ] High

Availability: [ x ] Low [ ] Moderate [ ] High

Overall Risk Level: [ x ] Low [ ] Moderate [ ] High

Based on information provided by the ISSO, Privacy Office, system/data owner, or other security or privacy representative, it has been determined that this solicitation/contract involves:

[ x ] No PII [ ] Yes PII

4) Personally Identifiable Information (PII). Per the Office of Management and Budget (OMB)

Circular A-130, “PII is information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual.” Examples of PII include, but are not limited to the following: social security number, date and place of birth, mother‘s maiden name, biometric records, etc.

PII Confidentiality Impact Level has been determined to be: [ x ] Low [ ] Moderate [ ] High

5) Controlled Unclassified Information (CUI). CUI is defined as “information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information.” The Contractor (and/or any subcontractor) must comply with

Executive Order 13556, Controlled Unclassified Information, (implemented at 32 CFR, part

2002) when handling CUI. 32 C.F.R. 2002.4(aa) As implemented the term “handling” refers to

“…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re-using, and disposing of the information.” 81 Fed. Reg. 63323. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, shall be:

a. marked appropriately;

b. disclosed to authorized personnel on a Need-To-Know basis;

c. protected in accordance with NIST SP 800-53, Security and Privacy Controls for Federal

Information Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting Controlled Unclassified

Information in Nonfederal Information Systems and Organizations if handled by internal

Contractor system; and

6) returned to HHS control, destroyed when no longer needed, or held until otherwise directed.

mailto:fisma@hhs.gov http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf

Destruction of information and/or data shall be accomplished in accordance with NIST SP 800-

88, Guidelines for Media Sanitization. Protection of Sensitive Information. For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) shall protect all government information that is or may be sensitive in accordance with OMB

Memorandum M-06-16, Protection of Sensitive Agency Information by securing it with a FIPS

140-2 validated solution.

7) Confidentiality and Nondisclosure of Information. Any information provided to the contractor

(and/or any subcontractor) by HHS or collected by the contractor on behalf of HHS shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of

Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any HHS records may be made available or disclosed shall be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein.

The confidentiality, integrity, and availability of such information shall be protected in accordance…